One-Time Complete Revascularization Versus Staged PCI in MVD During Pharmaco-Invasive STEMI Strategy

One Time Complete Revascularization Versus Staged PCI in Multivessel Coronary Artery Disease During Pharmaco Invasive STEMI Strategy

This study compares two treatment strategies in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) undergoing a pharmaco-invasive approach after successful fibrinolysis. The study evaluates whether one-time complete revascularization, in which the culprit and significant non-culprit lesions are treated during the same percutaneous coronary intervention (PCI) session, is better than a staged strategy, in which non-culprit lesions are treated in a separate percutaneous coronary intervention (PCI) procedure within 1 month.

The hypothesis is that one-time complete revascularization may reduce hospitalization time, cost, and recurrent ischemic symptoms without increasing short-term complications.

Participants are adults with acute ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) who had successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention (PCI). Outcomes include total hospitalization time, total expenses, contrast-induced nephropathy (CIN) within 72 hours, and major adverse cardiovascular events (MACE) during 3 months of follow-up.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Procedure: One-Time Complete Revascularization; Procedure: Staged Percutaneous Coronary Intervention

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11795
      • Helwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults older than 18 years.
• Acute ST-elevation myocardial infarction treated with a pharmaco-invasive strategy.
• Successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention.
• Multivessel coronary artery disease.
• Ability to provide written informed consent.

Exclusion Criteria:

• Primary percutaneous coronary intervention.
• Unsuccessful fibrinolysis requiring rescue percutaneous coronary intervention.
• Candidacy for coronary artery bypass grafting after angiography.
• Failed complete revascularization.
• Cardiogenic shock.
• Single-vessel coronary artery disease treated with a pharmaco-invasive strategy.
• Stent thrombosis.
• Chronic total occlusion.
• Planned percutaneous transluminal coronary angioplasty to a non-culprit lesion in a vessel smaller than 2.5 millimeters with more than 70 percent stenosis.
• Severe valvular heart disease.
• Pregnancy.
• Prior cardiac surgery.
• Congenital heart disease.
• Severe hepatic impairment.
• Severe renal impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One-Time Complete Revascularization; Participants underwent one-time complete revascularization during the index percutaneous coronary intervention after successful fibrinolysis. The culprit coronary artery and all significant non-culprit lesions were treated during the same procedure.	Procedure: One-Time Complete Revascularization; Revascularization strategy in which the culprit coronary artery and all significant non-culprit lesions are treated during the index percutaneous coronary intervention session after successful fibrinolysis.
Active Comparator: Staged Percutaneous Coronary Intervention; Participants underwent culprit-only percutaneous coronary intervention during the index procedure after successful fibrinolysis. Significant non-culprit lesions were treated in a separate staged percutaneous coronary intervention session within 1 month after discharge.	Procedure: Staged Percutaneous Coronary Intervention; Revascularization strategy in which only the culprit coronary artery is treated during the index percutaneous coronary intervention session after successful fibrinolysis, with treatment of significant non-culprit lesions deferred to a separate staged percutaneous coronary intervention within 1 month after discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total hospitalization time	Total duration of hospitalization in days. For participants assigned to staged revascularization, the duration of the staged admission was added to the index admission to calculate the total hospitalization time.	up to 1 month post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total expenses	Total treatment-related expenses in Egyptian pounds for the index admission and, when applicable, the staged admission.	up to 1 month post operatively
Contrast-induced nephropathy	Increase in serum creatinine by at least 0.5 milligrams per deciliter or at least 25 percent from baseline within 72 hours after percutaneous coronary intervention.	Within 72 hours after percutaneous coronary intervention
Angina-related hospitalization	Hospital admission due to recurrent anginal symptoms during follow-up.	Within 3 months after index percutaneous coronary intervention
Left ventricular ejection fraction	Left ventricular systolic function assessed by transthoracic echocardiography using the modified Simpson method.	Baseline and 3 months after index percutaneous coronary intervention
Wall motion score index	Regional left ventricular wall motion score index assessed by transthoracic echocardiography.	Baseline and 3 months after index percutaneous coronary intervention
Serum creatinine	Serum creatinine concentration measured to assess renal function.	Baseline, 72 hours after percutaneous coronary intervention, and 3 months

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Helwan University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2023
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Fibrinolysis; Complete revascularization; ST-elevation myocardial infarction; Multivessel coronary artery disease; Pharmaco-invasive strategy; Staged percutaneous coronary intervention; Non-culprit lesion intervention; Primary percutaneous coronary intervention delay
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Coronary Artery Disease; Myocardial Infarction
• Other Study ID Numbers: 50-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in this study will be made available to qualified researchers. Shared data may include baseline demographic and clinical characteristics, procedural data, laboratory results, echocardiographic findings, hospitalization data, and follow-up outcome data used in the published analyses. All shared data will be fully de-identified to protect participant privacy.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the study results and will remain available for 5 years.
• IPD Sharing Access Criteria: Access will be provided to qualified researchers for scientifically sound research purposes after submission and approval of a methodologically appropriate proposal. Requests should include the study objectives, analysis plan, and intended use of the data. Data sharing will require approval by the principal investigator and institution, and may require a signed data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No